177Lutetium-DOTA-Octreotate Therapy in Somatostatin Receptor-Expressing Neuroendocrine Neoplasms
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ClinicalTrials.gov Identifier: NCT01237457 |
Recruitment Status : Unknown
Verified August 2015 by Ebrahim S. Delpassand, Excel Diagnostics and Nuclear Oncology Center.
Recruitment status was: Active, not recruiting
First Posted : November 9, 2010
Last Update Posted : August 5, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neuroendocrine Tumors | Drug: 177Lu-DOTATATE | Phase 2 |
(177)Lutetium-DOTA-Octreotate Therapy in Somatostatin Receptor-Expressing Neuroendocrine Neoplasms
First Annual Report on protocol IND# 78,256 at RITA Foundation in collaboration with Excel diagnostics and Nuclear Oncology center and Baylor College of Medicine
Protocol number 78,256 calls for recruitment of sixty patients on this protocol. As of August 15th, 2011, we have enrolled 23 patients on this study ages between 27 and 83 years old with average of 61.6. Among patients there were 22 Caucasians (95.7%) and 1 African American (4.3 %). Eleven of the patients were female (48%) age between 46 and 83 years old with average of 63.9 years old. Twelve male patients (52%) were treated with ages between 27 and 86 years old with average of 59.58 years old. 15 patients (65.2%) had Gastro-entero-pancreatic neuroendocrine tumor (GEPNET), 7 had carcinoid tumors (30.4%) and 1 had bronchial carcinoid (4.3%). All patients had progressive disease with multiple distant metastases that poorly responded to prior surgery, chemotherapy, radiotherapy, chemo-embolization or cold Octreotide treatments.
Full phase I dosimetry evaluation, including dosimetric evaluation of multiple urine and blood sample collections, was performed on 6 patients and submitted to FDA. Ten patients received one therapy with an average dose of 199mCi/patient (188.52-208.15 mCi). Eight patients received two cycles of therapies with an average dose 390.29mCi/patient (363.49-413.26 mCi). Two patients received three therapies with an average dose 592.11mCi/patient (587.52-596.7mCi) and three patients have received four therapies with an average dose of 787.62mCi/patient (784.21-794.28 mCi).
Toxicity
Patients were evaluated for any evidence of renal, hepatic or hematologic toxicity using NCI common toxicities criteria following each cycle of therapy. No significant acute toxicity was observed immediately following treatment, and no patients required supportive treatment during therapy. Of 23 evaluable patients, 6 patients (26%) had grade 2 or 3 hematological toxicity which no supportive therapy was required. Average duration of hematological toxicities grade 2 was 8.3 weeks (range 4-16 weeks) and 4.5 weeks (range 1-8 weeks) for toxicity grade 3. Grade 2 or 3 liver toxicity was observed in 2 patients (8.6%). In addition, 2 patients (8.6%) had renal toxicity grade 2. 11 patients (47.8%) had moderate or severe nausea/vomiting after their treatment recovered between 1 to 3 days after completion of therapy. In one patient (4.3%), skin flushing, sweating and diarrhea developed after the therapy which recovered within 48 hours following the therapy.
Response
Among 13 patients who have received 2 or more cycles of therapy, 4 (30%) had a partial response to treatment and 9 patients (70%) exhibited stable disease. No disease progression was noted.
4 patient deaths have been reported so far. None of these patients were able to complete all four cycles of the therapy. All patients died as a result of massive tumor burden. The average time interval between the death and the last treatment is 1.41 months (0.76-2.23 months).
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 177Lutetium-DOTA-Octreotate Therapy in Somatostatin Receptor-Expressing Neuroendocrine Neoplasms |
Study Start Date : | October 2010 |
Estimated Primary Completion Date : | August 2015 |
Estimated Study Completion Date : | October 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment |
Drug: 177Lu-DOTATATE
Patients will receive 200mCi dose of 177Lu Dotatate |
- Progression Free survival [ Time Frame: one year after completion of last treatment cycle ]Overall response will be determined by Progression Free Survival (PFS). PFS will be calculated as a function of time from start of therapy to time of overall disease progression. Patients will be censored at the date of last contact
- Dose limiting toxicity [ Time Frame: one year after completion of the fourth cycle of treatment ]Patients will be monitored for dose toxicity according to NCI guidelines

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with biopsy proven Gastroenteropancreatic (GEP tumors including bronchial carcinoids)
- Presence of somatostatin-receptors on the known tumor lesions demonstrated by OctreoScan within 6 months of the first dose of radiolabelled octreotate therapy. The uptake on the OctreoScan should be at least as high as normal liver uptake on planar imaging.
- Life Expectancy greater than 12 weeks.
- Serum creatinine ≤ 150 µmol/liter or 1.7 mg/dL and a measured creatinine clearance (or measured GFR using plasma clearance methods, not gamma camera based) of ≥ 50ML/min.
- Hemoglobin (Hgb) concentration ≥ 5.5 mmol/L (≥ 8.9 g/dL); WBC ≥ 2*109/L (2000/mm3); platelets ≥ 100*109/L (100*103/mm3).
- Total Bilirubin ≤ 3X UNL.
- Serum Albumin > 30g/L or serum albumin ≤ 30g/L but normal prothrombin time.
- All patients must have a Karnofsky performance status of at least 60%
- Patients must be greater than 18 years of age. Patients younger than 18 years will be presented to FDA for compassionate use on a case by case basis
Exclusion Criteria:
- Possible surgery with curative intent.
- Surgery, radiotherapy, chemotherapy or other investigational therapy within 3 months of the start of therapy.
- Patients with known brain metastases unless these metastases have been treated and stabilized for at least 6 months prior to study start. Patients with a history of brain metastases must have a head CT with contrast to document stable disease prior to study start.
- Uncontrolled congestive heart failure.
- Any subject who is taking concomitant medications which decrease renal function (such as aminoglycoside antibiotics).
- Any subject receiving therapy with somatostatin analogues, unless the dose has been stable for at least 3 months prior to the first cycle in this study and the disease status during these 4 months has been documented by modified RECISTS criteria as described in this study
- Any subject receiving therapy with short acting somatostatin analogues in whom these analogues cannot be interrupted for 12 hours before and 12 hours after the administration of the radio labelled somatostatin analogues, or any subject who receives therapy with long-acting somatostatin analogues in whom these analogues cannot be interrupted for at least 6 weeks before the administration of the radio labeled somatostatin analogues, unless the uptake on the Octreoscan during continued somatostatin analogue medication is at least as high as normal liver uptake on planar imaging.
- In patients with unusual hematological parameters, including an increased MCV (>105fL), and especially in those who had previous chemotherapy, the advice of a hematologist should be sought for adequate further work-up.
- Subjects with another significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study.
- Prior radiation therapy to more than 25% of the bone marrow.
- Female patients who are pregnant, lactating or women of childbearing potential not willing to practice effective contraceptive techniques during the study period and for 60 days (10 half lives of 177Lu after the last treatment, or male patients who have female partners of childbearing potential not willing to practice abstinence or effective contraception, during the study period and for 60 days after the last treatment

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01237457
United States, Texas | |
Excel Diagnostics and Nuclear Oncology Center | |
Houston, Texas, United States, 77042 |
Principal Investigator: | Ebrahim S Delpassand, M.D | Excel Diagnostics and Nuclear Oncology Center |
Responsible Party: | Ebrahim S. Delpassand, Chairman and Medical Director, Excel Diagnostics and Nuclear Oncology Center |
ClinicalTrials.gov Identifier: | NCT01237457 |
Other Study ID Numbers: |
78,256 |
First Posted: | November 9, 2010 Key Record Dates |
Last Update Posted: | August 5, 2015 |
Last Verified: | August 2015 |
Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms, Nerve Tissue Lutetium Lu 177 dotatate Radiopharmaceuticals Molecular Mechanisms of Pharmacological Action |